临床试验/NCT02904603

NCT02904603Unknown不适用

Prospective Monitoring of Immune Parameters in Patients With Hepatitis C Under Treatment With Direct Acting Antivirals

University of Regensburg1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2014年11月最近更新: 2016年9月21日

适应症

试验速览

阶段: 不适用
发起方: University of Regensburg
入组人数: 100
试验地点: 1
主要终点: Change of IP10 and related cytokines during treatment (ng/ml)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Direct acting antivirals offer a new opportunity to monitor the immune response in Hepatitis C infection. In this study cytokine markers will be measured during therapy up to time point SVR 12 an correlated to clinical Parameters and regular laboratory findings.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 100 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•written consent, age, HCV-RNA positive, DAA therapy

排除标准

未提供

结局指标

主要结局

Change of IP10 and related cytokines during treatment (ng/ml)

时间窗: 24 weeks (observation time under and after DAA therapy)

Screening for Biomarkers under DAA Therapy until timepoint SVR 12 (12 weeks treatment plus control 12 weeks after end of Treatment = 24 weeks)

次要结局

SVR 12(24 weeks (12 weeks treatment plus control 12 weeks after end of treatment))
Change of inflammatory markers (ferritin ng/ml, CRP mg/l, PCT ng/ml) during treatment(24 weeks (observation time under DAA therapy))

研究者

发起方

University of Regensburg

申办方类型

Other

责任方

Principal Investigator

主要研究者

Dr. Georg Peschel

Dr. med.

University of Regensburg

研究点 (1)

Loading locations...

相似试验

Unknown

2 期

Antiviral Agent HARVONI® for the Treatment of HCV-associated Indolent B-Cell LymphomaIndolent Lymphoma

NCT03261349National Taiwan University Hospital21

已完成

不适用

Hepatitis C Virus and the Humoral Immune SystemHepatitis C Virus

NCT00219999Rockefeller University161

已完成

不适用

An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis CHepatitis C, Chronic

NCT03423641Kaiser Permanente33,808

已完成

2 期

Response Modifier (Arabinoxylan Rice Bran/MGN-3/Biobran) With Interferon-Alpha for HCVHepatitis C, Chronic

NCT02690103Cairo University37

招募中

不适用

Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Cancer DevelopmentHepatitis C Virus Infection

NCT06718530Centro di Riferimento Oncologico - Aviano1,000